RecruitingNot ApplicableNCT05896865

Radiotherapy Dose Adaptation Based on Tumor Biology in Patients With cN2b-N3 Breast Cancer

Radiotherapy Dose Adaptation Based on Tumor Biology in Patients With cN2b-N3 Breast Cancer: Non-randomized Phase II, Prospective Single Arm Study Clinical Trial

Sponsor

Samsung Medical Center

Enrollment

120 participants

Start Date

Mar 16, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Stage III

Summary

The purpose of the study is to evaluate treatment outcomes of breast cancer with internal mammary or supraclavicular lymph node metastasis according to total radiation dose of postoperative radiation therapy differentiated by tumor response to neoadjuvant chemotherapy. The main questions it aims to answer are: * 5-year disease-free survival * 5-year overall survival * 5-year locoregional recurrence * Adverse events after radiation therapy * Quality of life Participants will be assessed by multi-dimensional methods before and after radiotherapy: * Disease status evaluation including physical and radiological examination * Quality of life assessment with questionnaires (BREAST-Q) * Adverse event assessment according to CTCAE version 5.0

Eligibility

Sex: FEMALEMin Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether radiation therapy doses can be adjusted — reduced or increased — based on how a patient's breast cancer responds to chemotherapy before surgery, specifically for women with cancer that has spread to lymph nodes near the breastbone or collarbone. **You may be eligible if...** - You are a woman aged 19 or older - You have breast cancer that has spread to internal mammary or supraclavicular lymph nodes, confirmed by imaging or biopsy - You have received chemotherapy before surgery (neoadjuvant chemotherapy) - You underwent breast-conserving surgery or mastectomy - Your general health is reasonably good (ECOG status 0–2) **You may NOT be eligible if...** - You have received previous radiation therapy to the chest - Your cancer has spread to distant parts of the body (stage IV) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONWhole breast / chest wall & regional lymph node irradiation

Whole breast / chest wall and corresponding regional lymph node irradiation with dose of 42.4 Gy in 16 fractions

RADIATIONInternal mammary or supraclavicular lymph node boost

Simultaneous boost to Internal mammary or supraclavicular lymph node area with dose of total 53.6 Gy or 56.0 Gy in 16 fractions, depending on the response after neoadjuvant chemotherapy